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Position Executive Director, Clinical Development - Oncology- US - North Carolina, Raleigh & Canada - Quebec, Montreal INC Research
Company INC Research
Location North Carolina
Country United States
Job Description Executive Director, Clinical Development - Oncology

Executive Director, Clinical Development - Oncology

INC Research, a global therapeutically-focused CRO, is currently seeking an experienced clinicla research professional for an Executive Director opportunity within our Oncology therapeutic group. This office-based position oversees business aspects of clinical operations for the assigned therapeutic area to achieve target revenue and profitability while ensuring the contracted services and expectations of all projects are carried out by the INC Research (INCR) project teams in accordance with executed contracts and Customers’ expectations. Duties include management of staff utilization and realization of project revenue for therapeutic area (TA), analysis of financial data, assuming role of primary liaison with Customers, Vendors, Senior Management and Investigator sites as needed, and organizing department hierarchy and processes to achieve targets. Includes line management responsibilities for project management staff within the therapeutic area.

Essential functions of this position include:

1. Acts as overseer for all TA projects to ensure study launch, conduct and closeout occurs according to the Customer’s and INCR’s contractual agreement. Ensures studies progress according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfill al federal and local regulations.

2. Plans and negotiates resources across TA with line management to better achieve revenue and employee retention goals while building for growth.

3. Responsible for implementation of all Operations Management systems and processes within TA. Supports Operations Management staff in development of work processes and standards.

4. Works with senior management and Business Development to set strategic direction for TA to better target types of projects across selected customer segments, and makes recommendations regarding differentials to be applied to billing rates, experience levels, etc. by customer segment.

5. Supports Business Development strategies for award and market share growth via Customer presentations, participation in bid defenses, collation of pertinent study conduct information, and networking.

6. Reviews all proposals for TA and participates in strategy calls. Works with Proposal/Contracts group to develop proposals for Customer requested opportunities. Works with Proposals and Contracts to set billing rates.

7. Evaluates progress of TA projects, and of TA staff, via analysis of utilization and realization data, timelines, financial data and other information made available. Produces and distributes status, resourcing and tracking reports as well as functional area plans to senior management for development of process improvement plans or maintenance plans for high performing projects in the TA.

8. Actively manages and mentors Project Management staff (which may include: Senior/Project Directors; Senior/Project Managers; and Project Management Associates) in general team leadership skills, customer management skills, project management skills, internal INCR processes, and for project specific tasks.

9. As necessary, troubleshoots difficulties which may arise in project conduct between INCR and Customer, and/or between Clinical Development. Facilitates team building and communication. Acts as a liaison and facilitator between other functional areas within INCR for overall operational issues.

10. Develops knowledge of current therapeutic environment and drug development trends as needed. Facilitates team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training. May review protocol to ensure sponsor’s objectivesa re met and are inline with their Drug Development Program, as well as fulfilling FDA or other regulatory bodies’ guidelines.

11. Reviews and approves information from project managers/directors for internal review meetings.

12. Serves as Project Advisor to project teams regarding the political and operational aspects of projects, and customer satisfaction. Manages projects ranging in size and complexity from single service studies to large full scope, multiple protocol projects, global projects and/or programs (including drug development programs), with minimal interaction from supervisor. This includes management of resources, tasks, risk and quality. Manages the executed contract and financial aspects of assigned projects/programs. Reviews and approves study budgets and expenses and ensures all study related contractual and budgeting issues are upheld and performed. Oversees and tracks site payment issues as required. Ensures customers are invoiced in a timely manner and follows up on receipt of payment.

13. Develops knowledge of current therapeutic environment and drug development trends as needed. Facilitates team training in accordance with protocol and/or project requirements.

This position requires a PhD or medical degree with at least 2-5 years spent actively managing Oncology clinical research projects across functional areas, and other relevant experience is advantageous. Previous supervisory experience and pharma/CRO experience is required. Thorough knowledge of FDA regulations, drug development, and clinical monitoring procedures is necessary. Must have demonstrated proficiency with ICH/GCP guidelines. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail is required. Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment is essential. Requires strong presentation, documentation and interpersonal skills as well as a team-oriented approach.

At INC Research, It's "All About the Process"

For more than two decades, INC Research has been a therapeutically focused contract research organization with an unrivaled reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I - Phase IV programs in therapeutic areas of specialty, and in innovative pediatric trials. Our Trusted Process™ methodology and therapeutic foresight leads our customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, North Carolina, and has a presence in 40 locations worldwide.

INC Research is pleased to offer our employees a comprehensive benefits plan that includes: Healthcare Coverage (Medical/Dental/Vision), Flexible Spending Accounts, 401(k), Life Insurance and AD&D, Short- and Long-Term Disability, Supplemental Income Protection, Employee Assistance Program, Paid Time Off and Paid Holidays.


We offer a competitive salary and comprehensive benefits package. For immediate consideration, please email your CV with salary requirements to: (Email submissions preferred.)
Company Profile INC Research is a therapeutically focused global contract research organization (CRO) with unrivaled expertise and a reputation for conducting global clinical development programs of the highest integrity. INC Research has a deep-rooted history of therapeutic expertise and technological innovation. Founded more than two decades ago as an academic research organization focused on CNS research, we've translated that expertise into a global organization with the added specialties of infectious diseases, oncology and pediatrics, as well as full data services capabilities.
Job Type Full Time
Salary Upto 0  $   Per Month
Skills Required Business Development
Reference EDONC0909SW
Posted On 24 November 2009
Last Date to Apply 25 December 2009
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